# Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (Text with EEA relevance), Division 18

Extent: E+W+S+N.I.

If a clinical trial is conducted with an active substance available in the Union under different trade names in a number of authorised medicinal products, the protocol may define the treatment in terms of the active substance or Anatomical Therapeutic Chemical (ATC) code (level 3-5) only and not specify the trade name of each product.

---
Source: https://www.legislation.gov.uk/eur/2014/536/annex/I/division/D/division/18 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-D/division-18
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.